Overview

Metabolic Characteristics of Sarcoma In Vivo Using HP 13-C Magnetic Resonance Spectroscopic Imaging (MRSI)

Status:
Enrolling by invitation
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
Summary
Investigators will determine whether MRSI using hyperpolarized [1-13C]pyruvate provide useful information of tumor malignancy in MRI-indeterminate cases. Metabolite maps of hyperpolarized [1-13C]lactate and H13CO3- produced from hyperpolarized [1-13C]pyruvate will be compared to the biopsy results of MRI-indeterminate patients and the 13C-maps of age-matched healthy subjects.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Criteria
Inclusion Criteria:

SARCOMA patients:

- MRI indeterminate solid enhancing lesion in the pelvis or extremity.

ALL subjects:

- Age 18 through 100 years.

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately.

- Ability to understand and the willingness to sign a written informed consent.

- All races and ethnicities will be included; subjects must be able to read and speak
the English or Spanish language.

Exclusion Criteria:

SARCOMA patients:

-Subjects who have had radiotherapy to the indeterminate lesion.

ALL subjects:

- Subjects who have had chemotherapy within 4 weeks prior to entering the study or those
who have not recovered from adverse events due to agents administered more than 4
weeks earlier.

- Subjects may not be receiving any other investigational agents.

- Any contraindication per MRI Screening form including implants contraindicated at 3T,
pacemakers, implantable Cardioverter Defibrillator (ICD), claustrophobia.

- Metallic foreign bodies in the field of view which may interfere with MRI
acquisitions.

- Since each subject is receiving a gadolinium based contrast agent intravenously,
additional contraindications would include: eGFR ≤ 30 mL/min/1.73m2, sickle cell
disease, or hemolytic anemia.

- Uncontrolled psychiatric illness/social situations that would limit compliance with
study requirements.

- Subjects must not be pregnant or nursing due to the potential for congenital
abnormalities and the potential of this regimen to harm nursing infants.